In-Vitro Diagnostics Manufacturing Services
ZYPS has assisted over 30 in-vitro diagnostics (IVD) manufacturers to date. We handle all regulatory and compliance requirements with ease.
Contact UsContact
Lets get in touch
Comprehensive IVD Consulting Services
Select ZYPS for your regulatory requirements. Our demonstrated leadership, ethical standards, and effectiveness have garnered a clientele of over 50 satisfied customers, including major industry players. We ensure flawless submissions and offer a seamless end-to-end process. Rely on us as your top choice regulatory collaborator and benefit from our comprehensive service offerings.
CDSCO – How it governs medical device regulatory affairs
The CDSCO oversees the regulation of in-vitro diagnostic (IVD) devices in India, encompassing their manufacturing, importation, and sales. It has established a regulatory framework mandating compliance with various requirements such as registration, classification, clinical performance evaluation, labeling, adverse event reporting, and post-market surveillance for IVD manufacturers. Adherence to these regulations is crucial to guarantee the safety and efficacy of IVD products in India. The CDSCO's primary role involves enforcing these regulations, monitoring the quality and safety of IVD devices, and taking necessary measures in instances of non-compliance. Through these efforts, the CDSCO plays a vital role in safeguarding the health of the Indian populace by ensuring the safety and effectiveness of IVD devices.
